FDA device listing
GenASIs HiPath IHC Family,HiPath Pro IHC Family,PathFusion HiPath IHC Family
FDA device listing 1096594090 · APPLIED SPECTRAL IMAGING Ltd.
Key facts
| Proprietary names | GenASIs HiPath IHC Family,HiPath Pro IHC Family,PathFusion HiPath IHC Family |
|---|---|
| Owner/operator | APPLIED SPECTRAL IMAGING Ltd. |
| Owner/operator number | 9031915 |
| Premarket submissions | K140957 |
| Product codes | NOT, NQN |
| Device names | NOT - Microscope, Automated, Image Analysis, Operator Intervention, NQN - Microscope, Automated, Image Analysis, Immunohistochemistry,Operator Intervention,Nuclear Intensity & Percent Positivity |
| Device class | Class II |
| Classification regulations (21 CFR) | 864.1860 |
| Review panels | Hematology |
| Registered establishments | APPLIED SPECTRAL IMAGING, LTD. |
| Establishment registrations | 9615060 |
| FEI numbers | 3009505338 |
| Establishment operations | Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 1–9 UDI devices (GUDID) under the same submission
- 1–9 Device listings citing the same submission
- Yes Premarket submission listed
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device listings
Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.
Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database